Small Phase I melanoma study testing a combination of Zelboraf and Yervoy was closed early due to an unexpectedly high rate of liver toxicity, investigators report in letter to the editor of the New England Journal of Medicine. A sequential study of Yervoy and Zelboraf and other combination studies proceed as planned.
An eagerly awaited Phase I/II study of Roche’s Zelboraf and Bristol-Myers Squibb Co.’s Yervoy has been terminated due to liver toxicity, but the drugs still could find a role for use in immediate sequence.
Both Bristol’s CTLA inhibitor Yervoy (ipilimumab) and Roche’s BRAF inhibitor Zelboraf (vemurafenib) revolutionized the melanoma field when they cleared FDA...
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
